NCT05839873
Active, not recruiting
Not Applicable
Abbott Ventricular Tachycardia Post Approval Study
ConditionsVentricular Tachycardia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ventricular Tachycardia
- Sponsor
- Abbott Medical Devices
- Enrollment
- 62
- Locations
- 11
- Primary Endpoint
- Rate of study device- and/or Study Ablation Procedure-related SAEs through 12 months post Index Ablation Procedure.
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
This post-approval study (PAS) is designed to provide continued clinical evidence to confirm the long-term safety and effectiveness of the FlexAbilityTM Ablation Catheter, Sensor EnabledTM (FlexAbility SE) for the treatment of ventricular tachycardia in a post-market environment. This is a prospective, single arm, open-label, multi-center, observational study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient or legally acceptable representative or parent/guardian (as applicable) must provide written informed consent prior to any clinical investigation-related procedure
- •Subjects who have recurrent, drug-refractory, sustained MMVT with non-ischemic structural heart disease and a clinical decision has been made to use FlexAbility SE for an ablation procedure prior to enrollment in the research study
- •Refractory (i.e. not effective, not tolerated or not desired) to at least one Class I/III anti-arrhythmic medication for treatment of MMVT
- •Implanted with a market released ICD or CRT-D prior to the Index Ablation Procedure
- •Able and willing to comply with all study requirements
Exclusion Criteria
- •Documented or known intracardiac thrombus or myxoma
- •Active systemic infection
- •History of atriotomy or ventriculotomy within 4 weeks prior to the Index Ablation Procedure
- •Patients with prosthetic valves as the catheter may damage the prosthesis
- •Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
Outcomes
Primary Outcomes
Rate of study device- and/or Study Ablation Procedure-related SAEs through 12 months post Index Ablation Procedure.
Time Frame: 12 Month
Composite of 12-month freedom from VT recurrence, death, and cardiac transplantation
Time Frame: 12 Month
Study Sites (11)
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